Nifedipine sustained release tablets and preparation process thereof

A technology for nifedipine and preparation process, which is applied in the directions of non-active ingredient medical preparations, medical preparations containing active ingredients, and pill delivery, etc. problem, to achieve the effect of slow dissolution rate, simple production process, and easy mass production

Active Publication Date: 2012-06-27
浙江泰利森药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the existing nifedipine sustained-release tablets still have unsatisfactory parts such as short duration of action (generally 12 hours, taking 2 times a day), often accompanied by adverse reactions; Dipine controlled-release tablets, although their drug release

Method used

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  • Nifedipine sustained release tablets and preparation process thereof
  • Nifedipine sustained release tablets and preparation process thereof
  • Nifedipine sustained release tablets and preparation process thereof

Examples

Experimental program
Comparison scheme
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Example Embodiment

[0016] Example 1

[0017] The sustained-release nifedipine tablets of the present invention are prepared from the following raw materials and auxiliary materials in the following weight ratios:

[0018] Nifedipine 20%

[0019] Chitosan 14%

[0020] Dextrin 60%

[0021] Ethyl cellulose 4%

[0022] Sodium lauryl sulfate 1%

[0023] Magnesium stearate 1%

[0024] Among them, nifedipine is a raw material, chitosan is a slow release agent, dextrin is a filler, ethyl cellulose is a binder, sodium lauryl sulfate is a solubilizer, and magnesium stearate is a lubricant.

[0025] Preparation process: pulverize nifedipine and pass it through a 200-mesh stainless steel sieve; mix nifedipine, chitosan, sodium lauryl sulfate and dextrin by weight percentage; after the raw and auxiliary materials are evenly mixed, add ethyl Ethyl cellulose with a weight concentration of 8% made by adding 80% ethanol to the cellulose—a soft material made of 80% ethanol solution; the soft material is passed through a 20-me...

Example Embodiment

[0026] Example 2

[0027] The sustained-release nifedipine tablets of the present invention are prepared from the following raw materials and auxiliary materials in the following weight ratios:

[0028] Nifedipine 20%

[0029] Chitosan 17%

[0030] Dextrin 57%

[0031] Ethyl cellulose 4%

[0032] Sodium lauryl sulfate 1%

[0033] Magnesium stearate 1%

[0034] Among them, nifedipine is a raw material, chitosan is a slow release agent, dextrin is a filler, ethyl cellulose is a binder, sodium lauryl sulfate is a solubilizer, and magnesium stearate is a lubricant.

[0035] Preparation process: crush nifedipine and pass it through a 200-mesh stainless steel sieve; mix nifedipine, chitosan, sodium lauryl sulfate and dextrin by weight percentage; add ethyl cellulose after the raw and auxiliary materials are evenly mixed —80% ethanol solution to make soft materials; pass the soft materials through a 20-mesh stainless steel sieve to make wet granules; dry the wet granules at a temperature of 55℃~6...

Example Embodiment

[0036] Example 3

[0037] The sustained-release nifedipine tablets of the present invention are prepared from the following raw materials and auxiliary materials in the following weight ratios:

[0038] Nifedipine 20%

[0039] Chitosan 20%

[0040] Dextrin 54%

[0041] Ethyl cellulose 4%

[0042] Sodium lauryl sulfate 1%

[0043] Magnesium stearate 1%

[0044] Among them, nifedipine is a raw material, chitosan is a slow release agent, dextrin is a filler, ethyl cellulose is a binder, sodium lauryl sulfate is a solubilizer, and magnesium stearate is a lubricant.

[0045] Preparation process: crush nifedipine and pass it through a 200-mesh stainless steel sieve; mix nifedipine, chitosan, sodium lauryl sulfate and dextrin by weight percentage; add ethyl cellulose after the raw and auxiliary materials are evenly mixed —80% ethanol solution to make soft materials; pass the soft materials through a 20-mesh stainless steel sieve to make wet granules; dry the wet granules at a temperature of 55℃~6...

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Abstract

The invention discloses nifedipine sustained release tablets and a preparation process thereof. The nifedipine sustained release tablets are prepared from nifedipine, a sustained release agent, a bulking agent, a bonding agent, a solubilizer and a lubricant by the steps of pulverizing, sieving, mixing, granulating, drying, tabletting and film coating. The sustained release agent adopts chitosan, and weight percentages of the components are as follows: nifedipine 20%, chitosan 14-24%, bulking agent 50-60%, bonding agent 4%, solubilizer 1%, and lubricant 1%. The nifedipine sustained release tablets of the invention are simple in production process and long in sustained release action, the adverse reactions after administration are less and mild, and the curative effect on mild and moderate hypertension is definite. The nifedipine sustained release tablets can uniformly release nifedipine within 24 hours, can last the effective blood concentration over 24 hours, and only need to be administered once everyday.

Description

technical field [0001] The invention relates to the field of drug sustained-release preparations, in particular to a nifedipine sustained-release tablet and a preparation process thereof. Background technique [0002] Nifedipine is one of the calcium antagonists. It is a blood pressure lowering drug. It has a strong effect of dilating coronary arteries and peripheral arteries, and has a significant effect of inhibiting vasospasm. Due to the short half-life of nifedipine ordinary tablets (about 2.0 hours) and short maintenance time, patients need to take the medicine multiple times (3 to 4 times a day) to achieve the purpose of lowering blood pressure. Because the release rate of common nifedipine preparations is not stable, the blood drug concentration in the human body fluctuates greatly, and side effects such as dizziness, flushing and heart palpitations are likely to occur. The human body releases it slowly and evenly at a certain speed, so that the drug effect is mo...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K9/28A61K31/4422A61K47/36A61K47/38A61P9/12
Inventor 肖亚宝崔生法文君韩风
Owner 浙江泰利森药业有限公司
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